Cystic Fibrosis Clinical Trial
Official title:
Proton Pump Inhibitors (PPI) and Fat Absorption in Subjects With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
Verified date | April 2024 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a clinical trial with a cross over design investigating the effect of the proton pump inhibitor omeprazole on fat malabsorption in subjects with cystic fibrosis and pancreatic insufficiency. Participants will be randomized to receive either omeprazole or placebo for 28 days, then cross over and receive omeprazole or placebo for another 28 days. Markers of fat absorption will be measured after each treatment course.
Status | Completed |
Enrollment | 19 |
Est. completion date | November 2, 2022 |
Est. primary completion date | November 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - Cystic fibrosis and pancreatic insufficiency (Fecal elastase <200 ug/g stool) - Age =12 years - In usual state of good health - Willing to participate in a four-month study with three visits Exclusion Criteria: - Forced expiratory vital capacity at one second (FEV1) <40% predicted - Pregnancy or breast feeding - Other illness affecting growth or nutritional status - Unwillingness to continue their clinically established PERT dose for the duration of the study - Use of other medication that affects dietary fat absorption - Allergy to soy products - Allergy to safflower products - For subjects =18 years, celiac disease or allergy to gluten |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Chiesi USA, Inc. |
United States,
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Heijerman HG, Lamers CB, Bakker W. Omeprazole enhances the efficacy of pancreatin (pancrease) in cystic fibrosis. Ann Intern Med. 1991 Feb 1;114(3):200-1. doi: 10.7326/0003-4819-114-3-200. — View Citation
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Stallings VA, Mondick JT, Schall JI, Barrett JS, Wilson M, Mascarenhas MR. Diagnosing malabsorption with systemic lipid profiling: pharmacokinetics of pentadecanoic acid and triheptadecanoic acid following oral administration in healthy subjects and subjects with cystic fibrosis. Int J Clin Pharmacol Ther. 2013 Apr;51(4):263-73. doi: 10.5414/CP201793. — View Citation
* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coefficient of Fat Absorption | Gold standard measurement of fat malabsorption | After 28 days of treatment or placebo | |
Secondary | Duodenal pH | Change in duodenal pH as measured by the motility testing system (SmartPill) | After 28 days of treatment or placebo | |
Secondary | Fat Absorption Via Malabsorption Blood Test | Measurement of serum pentadecanoic acid and heptadecanoic acid | After 28 days of treatment or placebo |
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